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Completed

NCT Number: NCT05389566

Diabetes, Falls, and Fractures

Comparing severity of diabetic peripheral neuropathy (small and large fibers including autonomic neuroapthy) to postural control and vestibular measurements

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Key information

Conditions

Diabetic Peripheral Neuropathy Atrophy Autonomic Neuropathy, Diabetic Balance; Distorted Cranial Nerve Diseases Diabetes Diabetes Complications Diabetes Mellitus Diabetic Neuropathies Ear Diseases Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Muscle Weakness Muscular Atrophy Muscular Diseases Musculoskeletal Diseases Nervous System Diseases Neurologic Manifestations Neuromuscular Diseases Neuromuscular Manifestations Nutritional and Metabolic Diseases Otorhinolaryngologic Diseases Pathologic Processes Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms Peripheral Nervous System Diseases Retrocochlear Diseases Sarcopenia Signs and Symptoms Small Fiber Neuropathy Vestibular Neuronitis Vestibular Neuropathy Vestibulocochlear Nerve Diseases

Age range

40 year–70 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Aalborg University Hospital

Aalborg, 9000, Denmark

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Men and women with minimum 40 years of age and maximum 70 years of age.
  • Diagnosis of T1D or T2D
  • Diagnosis of diabetes with at least one year prior to inclusion of the study
  • Signed the informed consent.

Exclusion criteria

  • Severe decreased liver function (Alanin amino-transaminase (ALAT)>250u/l, GammaGlutamyltransferase (GGT)>150u/l)
  • Moderate to severe kidney dysfunction, estimated Glomerular Filtration Rate (eGFR) <15mmol/L/1,73m2
  • Pregnancy or breast feeding
  • Active malignancy or terminal ill.
  • Current or previous alcohol- or drug abuse
  • Not being able to understand Danish written and/or verbally 9. Terms according to investigators judgement that makes subjects unsuitable to participate including lack of understanding or reduced physical ability. 10. Participating in other clinical studies 11. Maximum of 10 hours of weekly exercise.

Treatment and study plan

Quantative Sensory Testing

Diagnostic Test

Evaluation of small fiber neuropathy

NCStat-DPN-Check

Diagnostic Test

Evaluation of large fiber neuropathy

Composite Autonomic Symptom Score 31

Diagnostic Test

Evaluation of autonomic neuropathy

Computerized Dynamic Posturography

Diagnostic Test

Evaluation of dynamic postural control

Other names: Bertec

video Head Impulse Test

Diagnostic Test

Evaluation of vertigo and the vestibular organ

Other names: V-Hit

Accelerometer

Diagnostic Test

Evaluation of gait pattern

Other names: Sens Innovation, Copenhagen Denmark

Handgrip strength

Diagnostic Test

Evaluation of muscle strength

Other names: Hydraulic dynamometer, Saehan Coorporation, Gyungnam, South Korea

Dual Energy X-ray Absorbtimetry scan

Diagnostic Test

Evaluation of body composition

Other names: Dexa, Hollogic Horizon (4500 Hollogic Inc., Marlborough, MA, USA)

Force Plate Platform

Diagnostic Test

Evaluation of balance while standing still

Other names: Plux Biosignals, S.A, Arruda dos Vinhos, Portugal

Primary outcomes

  1. Co-existence of peripheral- and vestiubular neuropathy in people with diabetes

    Time frame: through study completion, an average of 2 years

    Vestibular neuropathy (measured by pathological video head impulse test (v-Hit) (one-sided, two-sided or specific arcways)) will be compared with peripheral neuropathy (measured by quantitative sensory testing, nerve conduction and COMPASS-33) in the population with diabetes.

  2. Co-existence of peripheral neuropathy and impaired dynamic postural control in people with diabetes

    Time frame: through study completion, an average of 2 years

    Dynamic balance (measured by Bertec) will be compared with peripheral neuropathy (measured by quantitative sensory testing, nerve conduction and COMPASS-33) in the population with diabetes.

Secondary outcomes

  1. Correlation between the severity of peripheral neuropathy and the severity of vestibular in terms of degree of pathological video head impulse testingneuropathy

    Time frame: through study completion, an average of 2 years

    QST / NC-Stat DPNCheck vs v-Hit

  2. Correlation between distal neuropathy and dynamic postural control (including patterns)

    Time frame: through study completion, an average of 2 years

    QST / NC-Stat DPNCheck vs accelerometer / Bertec

  3. The impact of peripheral neuropathy on postural control (In quite stance)

    Time frame: through study completion, an average of 2 years

    QST / Correlation between muscle strength and peripheral neuropathy vs Force Plate

Other outcomes

  1. Exploratory

    Time frame: through study completion, an average of 2 years

    accelerometer (SENS Innovation, Copenhagen, Denmark) measures (postural control during walking)

  2. Exploratory

    Time frame: through study completion, an average of 2 years

    Correlations between different outcomes of Bertec and v-Hit vs peripheral neuropathy (all individual examinations and arcways)

  3. Muscle strength and peripheral neuropathy

    Time frame: through study completion, an average of 2 years

    Correlation between muscle strength and peripheral neuropathy (DEXA-scans, hand grup strength, QST, Correlation between muscle strength and peripheral neuropathy

Sponsors and collaborators

Lead sponsor

Aalborg University Hospital

Other

Collaborators

  • Aalborg University

Registry information

Acronym: DIAFALL

Important dates

Study start
2022
Primary completion
2022
Study completion
2022
First posted
May 25, 2022
Registry last updated
Aug 9, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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